What is Lipaglyn (Saroglitazar) used for?

Lipaglyn (Saroglitazar) Uses

Lipaglyn (saroglitazar) is primarily indicated for the treatment of diabetic dyslipidemia in patients with type 2 diabetes mellitus, and has demonstrated additional benefits in non-alcoholic fatty liver disease (NAFLD). 1

Primary Indications

Diabetic Dyslipidemia

• Saroglitazar was approved in India in 2013 specifically for diabetic dyslipidemia, representing the first indigenously developed new chemical entity by an Indian pharmaceutical company. 1
• The medication provides once-daily oral therapy that simultaneously regulates both lipid parameters and glycemic control in patients with type 2 diabetes. 1
• Real-world evidence from 5,824 patients demonstrates consistent reductions in triglycerides (45-62%), total cholesterol (17-26%), non-HDL cholesterol (21-36%), and LDL cholesterol (11-27%), with increases in HDL cholesterol up to 9%. 2

Type 2 Diabetes Mellitus

• Saroglitazar significantly reduces fasting glucose (mean reduction 12.11 mg/dL), postprandial glucose (mean reduction 16.17 mg/dL), and HbA1c (mean reduction 0.39%). 3
• The glucose-lowering effect occurs through moderate PPAR-γ agonist activity, improving insulin sensitivity in peripheral tissues. 3, 4

Secondary Indications

Non-Alcoholic Fatty Liver Disease (NAFLD/NASH)

• In patients with NAFLD and diabetic dyslipidemia, saroglitazar 4 mg significantly improved liver parameters, including alanine aminotransferase (ALT) levels and liver fibrosis scores measured by FibroScan. 5
• A randomized controlled trial demonstrated that saroglitazar 4 mg reduced ALT by 45.8% compared to 3.4% with placebo (P < 0.001) over 16 weeks. 4
• Liver fat content decreased by 19.7% with saroglitazar 4 mg versus an increase of 4.1% with placebo. 4
• The medication improved insulin resistance (HOMA-IR reduction of 6.3 vs. 1.3 with placebo) and reduced lipotoxic lipid species that contribute to liver damage. 4

Mechanism of Action

• Saroglitazar functions as a dual PPAR agonist, predominantly activating PPAR-α (responsible for lipid effects) with moderate PPAR-γ agonist activity (responsible for glycemic effects). 1, 3
• The PPAR-α activation improves triglyceride metabolism and increases HDL cholesterol. 2
• The PPAR-γ activation enhances insulin sensitivity in peripheral tissues, improving glucose uptake and reducing hepatic glucose production. 4

Dosing and Administration

• The standard dose is saroglitazar 4 mg once daily, which has shown the most robust efficacy across lipid, glycemic, and hepatic parameters. 5, 2, 4
• Lower doses (1 mg and 2 mg) have been studied but demonstrate less pronounced effects compared to the 4 mg dose. 4

Safety Profile

• Saroglitazar has been well-tolerated in studies lasting up to 58 weeks, with no significant adverse events reported in real-world clinical practice. 2
• A modest mean weight gain of approximately 1.5 kg was observed with saroglitazar 4 mg, which is considerably less than traditional thiazolidinediones. 4
• Unlike rosiglitazone and pioglitazone, saroglitazar has not been associated with fluid retention, heart failure, or bone fractures in available studies. 5, 2, 4

Clinical Considerations

• Saroglitazar is particularly valuable for patients with the metabolic triad of type 2 diabetes, dyslipidemia, and NAFLD, as it addresses all three conditions simultaneously. 5, 2
• The medication improved adiponectin levels (increase of 1.3 μg/mL vs. decrease of 0.3 μg/mL with placebo), indicating improved metabolic health. 4
• Real-world studies included patients with mean ages ranging from 49.6 to 59.1 years, with 22-42% being female, demonstrating efficacy across diverse populations. 2